Hybrid Revascularization Observational Study

The purpose of the study is to get a better understanding of patients who have multi-vessel coronary artery disease (blockages in more than one vessel bringing blood to the heart) and have either Hybrid Coronary Revascularization [HCR] (combination of surgery and catheter procedures to open up clogged heart arteries) or Percutaneous Coronary Intervention [PCI] (catheter procedures to open up clogged heart arteries). Participation in the study will last up to 21 months after a patient's heart procedure(s). The study collects information about the medical care patients receive during their planned procedure(s) and how well they do following the procedure(s). No new testing or procedures will be done. Patients will receive only the tests or procedures their doctor already has planned for them. The information collected should help to plan the design of a pivotal comparative effectiveness study of hybrid revascularization.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

Detailed Description

The increasing prevalence of coronary artery disease (CAD), advances in coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), and concomitant medical therapy, and the costs of revascularization have resulted in rising interest regarding the appropriate indications for coronary revascularization. For patients with 3-vessel disease, revascularization by CABG has recently been rated as appropriate while revascularization by PCI has been rated uncertain. Ideally, physicians would like to offer their multi-vessel CAD patients what they truly seek: a solution which provides a safe, minimally invasive treatment that does not compromise long term durability and survival. Integrating the positive features of both PCI and CABG has been the fundamental rationale of "hybrid" coronary revascularization.

Hybrid Coronary Revascularization (HCR) (the intended combination of CABG and PCI) as a scientifically validated approach would have a major healthcare impact. The ability to deliver a new therapy for CAD that provides durability, but without the obligatory trauma and prolonged recovery time characteristic of conventional CABG would be a major advance in the field of cardiovascular medicine. Candidates in whom HCR would be particularly advantageous would be several subgroups of CAD patients that are increasing in numbers: the elderly, patients with a high predicted risk of mortality and/or morbidity for CABG, deconditioned patients or patients with significant disabilities and patients in whom treatment durability is important, but a significantly invasive approach is not an option. Moreover, HCR is likely to bridge the divide in treatment philosophies and approaches that exist between cardiologists and cardiac surgeons. Collaboration rather than competition between these specialties will ultimately benefit patients, hospitals, payers and healthcare providers. The Hybrid Revascularization Observational Study is a multi-center observational study planning grant which will explore target populations for Hybrid Coronary Revascularization (HCR), their outcomes, and variations in specific ways these patients are managed, in order to inform the design of a pivotal comparative effectiveness trial of this emerging therapeutic strategy.

Given the observational nature of the study, the HCR and PCI groups' baseline characteristics and event rates are not directly comparable; rather, the results were intended to inform the design of a larger, randomized pivotal trial. The study was designed in two phases: Cohort 1, which captured demographic, angiographic, and practice patterns data for 6,669 consecutively screened patients; and Cohort 2 which captured demographic, angiographic, practice patterns, and outcome data for 298 patients who underwent either HCR or PCI with DES (90 of whom were also part of Cohort 1).

• Study Type: Observational
• Enrollment (Actual): 298

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohort 1 (Angiogram Review Group): All consecutive and consenting patients undergoing diagnostic cardiac catheterization in a 3 month period.

Cohort 2 (Therapeutic Intervention Group): All patients (including those from cohort 1) who meet either of the following: (a) undergo HCR with minimally invasive LIMA-LAD CABG (HCR Group) OR (b) meet the proposed anatomic and clinical eligibility criteria defined below and undergo multivessel PCI with DES (PCI Group).

Description

The following criteria apply to Cohort 2 PCI patients only:

Inclusion Criteria:

• Signed informed consent, release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documents
• Age 18 years or older
• Clinical indication for revascularization
• LAD and at least one additional vessel coronary disease (> 70% stenosis) confirmed by angiogram
• Clinical characteristics and multi-vessel disease amenable to both PCI with DES and Hybrid as adjudicated by one interventional cardiologist and one cardiac surgeon
• Ability to tolerate and no plans to interrupt double platelet therapy for ≥ 12 months
• Ability to tolerate to single lung ventilation in the judgment of the investigator
• Willing to comply with all protocol required follow-up

Exclusion Criteria:

• Previous coronary stent within:

  • 1 month prior to enrollment for bare metal stent (BMS) or
  • 6 months prior to enrollment for DES
• Evidence of in stent restenosis of a DES or BMS
• Previous cardiac surgery of any kind
• Chronic total occlusion (CTO) in LAD or ≥ 2 CTOs in major coronary territories that are considered targets for revascularization
• Left main disease ≥ 50% stenosis
• Presence of fresh coronary thrombus
• Need for concomitant vascular or other cardiac surgery during the index hospitalization (including, but not limited to, valve surgery, aortic resection, left ventricular aneurysm, carotid endarterectomy or stenting, etc)
• Previous STEMI within 30 days prior to randomization
• Previous stroke within 6 months prior to randomization
• Previous thoracic surgery involving the left pleural space
• Acute decompensated heart failure within 30 days prior to randomization
• Ejection fraction < 30%
• Creatinine clearance ≤ 50 ml/min within 24 hours prior to randomization
• Hemodynamic instability at time of screening
• Body mass index > 40
• Extra-cardiac illness that is expected to limit survival to less than 3 years
• Participation or planned participation in another investigational intervention study within 60 days prior to randomization
• Unable to give informed consent or potential for noncompliance with the study protocol due to psychiatric illness, organic brain disease, dementia, current alcohol abuse, mental retardation, language barrier, or geographical inaccessibility;
• Pregnancy at time of screening or intention to become pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Angiogram Review Group; All consecutive and consenting patients undergoing diagnostic cardiac catheterization in a 3 month period
Therapeutic Intervention Group; Cohort 2 Therapeutic Intervention Group - HCR Patients (including those from the angiogram review group) who undergo Hybrid coronary revascularization (HCR) with minimally invasive LIMA-LAD CABG, OR; Cohort 2 Therapeutic Intervention Group - PCI Patients (including those from the angiogram review group) who meet the proposed anatomic and clinical eligibility criteria and undergo multivessel Percutaneous Coronary Intervention with Drug Eluting Stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac and Cerebrovascular Event (MACCE)	For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components: Death; Stroke; Myocardial Infarction; Repeat Revascularization	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac and Cerebrovascular Event (MACCE)	For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components: Death; Stroke; Myocardial infarction; Repeat revascularization	Occurence of MACCE through the end of study up to two years

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); International Center for Health Outcomes and Innovation Research
• Investigators: Principal Investigator: John Puskas, MD, MSc, FACS, FACC, Emory University; Principal Investigator: Deborah Ascheim, MD, Icahn School of Medicine at Mount Sinai (Data Coordinating Center); Principal Investigator: Joseph J DeRose, MD, FACS, Montefiore Medical Center; Principal Investigator: Michael Argenziano, MD, FACS, Columbia University; Principal Investigator: Mathew Williams, MD, Columbia University; Principal Investigator: John G. Byrne, MD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• Puskas JD, Halkos ME, DeRose JJ, Bagiella E, Miller MA, Overbey J, Bonatti J, Srinivas VS, Vesely M, Sutter F, Lynch J, Kirkwood K, Shapiro TA, Boudoulas KD, Crestanello J, Gehrig T, Smith P, Ragosta M, Hoff SJ, Zhao D, Gelijns AC, Szeto WY, Weisz G, Argenziano M, Vassiliades T, Liberman H, Matthai W, Ascheim DD. Hybrid Coronary Revascularization for the Treatment of Multivessel Coronary Artery Disease: A Multicenter Observational Study. J Am Coll Cardiol. 2016 Jul 26;68(4):356-65. doi: 10.1016/j.jacc.2016.05.032.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: May 10, 2010
• First Submitted That Met QC Criteria: May 11, 2010
• First Posted (Estimate): May 12, 2010

Study Record Updates

• Last Update Posted (Estimate): March 14, 2014
• Last Update Submitted That Met QC Criteria: February 7, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: coronary artery bypass; coronary angiography; coronary heart disease; drug-eluting stents; coronary arteriosclerosis; coronary artery bypass, off-pump
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: GCO 09-0657; 1RC1HL100951 (U.S. NIH Grant/Contract)